SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K080439
Device Name SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE
Applicant
MALLINCKRODT DEVELOPPEMENT FRANCE
6135 gunbarell ave.
boulder, 
CO 
80301

Applicant Contact tina dreiling
Correspondent
MALLINCKRODT DEVELOPPEMENT FRANCE
6135 gunbarell ave.
boulder, 
CO 
80301

Correspodent Contact tina dreiling
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 02/19/2008
Decision Date 05/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No